October 14, 2020 By Danielle Kirsh MDR mutual recognition agreement unresolved after Swiss referendum
September 23, 2020 By Danielle Kirsh Japan PMD Act revises fast-track reviews for some medical devices, IVDs
September 10, 2020 By Danielle Kirsh India regulators propose medical device, IVD extensive risk classification lists
September 8, 2020 By Danielle Kirsh U.K. regulators issue new post-Brexit medical device regulatory compliance guidance
August 26, 2020 By Nancy Crotti FDA IDs first medical device types eligible for streamlined 510(k) registration
August 19, 2020 By Danielle Kirsh Understanding clinical evidence requirements under European Medical Devices Regulation
July 2, 2020 By Danielle Kirsh How COVID-19 impacts FDA interactions with medical device manufacturers
June 16, 2020 By Danielle Kirsh How EU MDR and human factors affect design user-friendly software user interfaces
May 19, 2020 By Danielle Kirsh Eudamed updates phased implementation for European medical device, IVD database
